{"title":"猜猜谁要来视察研发部门了?","authors":"R.D. McDowall","doi":"10.56530/spectroscopy.cv2490n6","DOIUrl":null,"url":null,"abstract":"A new revision to the U.S. Food and Drug Administration (FDA)’s Compliance Program Guide for Pre-Approval Inspections (PAIs) has added a fourth objective: Commitment to Quality in Pharmaceutical Development. PAIs are going to be very interesting now.....","PeriodicalId":21957,"journal":{"name":"Spectroscopy","volume":"13 1","pages":"0"},"PeriodicalIF":0.8000,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Guess Who’s Coming to Inspect R&D?\",\"authors\":\"R.D. McDowall\",\"doi\":\"10.56530/spectroscopy.cv2490n6\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"A new revision to the U.S. Food and Drug Administration (FDA)’s Compliance Program Guide for Pre-Approval Inspections (PAIs) has added a fourth objective: Commitment to Quality in Pharmaceutical Development. PAIs are going to be very interesting now.....\",\"PeriodicalId\":21957,\"journal\":{\"name\":\"Spectroscopy\",\"volume\":\"13 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.8000,\"publicationDate\":\"2023-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Spectroscopy\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.56530/spectroscopy.cv2490n6\",\"RegionNum\":4,\"RegionCategory\":\"化学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"SPECTROSCOPY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Spectroscopy","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.56530/spectroscopy.cv2490n6","RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"SPECTROSCOPY","Score":null,"Total":0}
A new revision to the U.S. Food and Drug Administration (FDA)’s Compliance Program Guide for Pre-Approval Inspections (PAIs) has added a fourth objective: Commitment to Quality in Pharmaceutical Development. PAIs are going to be very interesting now.....
期刊介绍:
Spectroscopy welcomes manuscripts that describe techniques and applications of all forms of spectroscopy and that are of immediate interest to users in industry, academia, and government.